[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis (NCT07232459) | Clinical Trial Compass
RecruitingNot Applicable
[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis
China25 participantsStarted 2025-07-21
Plain-language summary
\[18F\]FT8, a derivative of 1-(4-pyridyl)-4-piperazinyl arene (\[18F\]TPZA), exhibits high affinity for AL amyloid in myocardial tissue sections and shows no significant binding to transthyretin amyloid. By comparing its diagnostic performance against established clinical methods, including echocardiography, contrast-enhanced MRI, and relevant laboratory tests, this study aims to establish \[18F\]FT8 as the basis for a robust PET protocol for the direct visualization and differential diagnosis of AL amyloidosis . The study preimarily evaluates the safety and diagnostic efficacy of \[18F\]FT8 PET imaging in human subjects.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult patients (age ≥ 18 years);
✓. Suspected, newly diagnosed, or previously diagnosed with cardiac amyloidosis, with supporting evidence from one or more of the following: cardiac MRI, contrast-enhanced CT, serum biomarkers (e.g., NT-proBNP, Troponin), or histopathological confirmation of amyloidosis.
✓. Scheduled to undergo a clinical Pan-Amyloid PET/CT scan as part of standard care or clinical evaluation.
Exclusion criteria
✕. Confirmed non-cardiac amyloidosis or other non-amyloid cardiac pathologies that could confound image interpretation.
✕. Pregnancy or breastfeeding.
✕. Any medical, psychological, or social condition that, in the opinion of the investigator, would compromise the subject's ability to participate fully or complete the study follow-up.
✕. Adult subjects (age ≥ 18 years);
✕. No clinical evidence of active cardiac or systemic disease, as confirmed by medical history review, physical examination, and electrocardiogram (ECG).
What they're measuring
1
The safety assessment
Timeframe: From time of injection up to 7 days post-injection
2
[18F]FT8 Organ Uptake measured by Standardized Uptake Value (SUV)
Timeframe: At the time of the single [18F]FT8 PET/CT scan (Day 1)